EpiCom : A Treatment Study of Tuberous Sclerosis Complex in Participants aged 2 to 18 years old

Summary

This study is for children age between 2 and 18 years who have tuberous sclerosis complex to take part in a 62 weeks long clinical research study. The primary purpose of this clinical
research study is to learn more about behavioral challenges and other non-seizure symptoms in patients with tuberous sclerosis complex who start EPID(I/Y)OLEX (an investigational study medicine) as add-on therapy for their seizures. Individuals will be evaluated to determine their eligibility to participate in this study. Each patient who
qualifies will receive the investigational medication, as well as study-related medical exams and study-related laboratory tests, at no cost. Compensation for time and travel may also, be available.


Eligibility

Currently recruiting participants: Yes

Eligible ages: 2 to 18

Inclusion criteria:

You or your child may be eligible to participate in this trial if you or your child

- 2 to 18 years of age
- Has a confirmed clinical diagnosis of Tuberous sclerosis complex with a history of seizures.

Doctors will also evaluate other criteria to make sure you and your child qualify for the study.

Exclusion criteria:

You or your child may not be eligible to participate in this trial if you or your child:
- Is currently pregnant, or breast feeding.
- Has a clinically significant unstable medical condition
- Currently enrolled in a clinical study

Participate

Fill out the following form if you want to participate in this research

Method of contact

Additional information

Contact information

Please contact Dr. Julia Jacobs-LeVan at 4039552480 or Julia.Jacobs- LeVan@albertahealthservices.ca

Principal investigator:

Julia Jacobs-Levan

Clinical trial:

Yes

REB-ID:

REB23-1683